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Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults (FLU-A)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00819013
First received: October 10, 2008
Last updated: January 16, 2012
Last verified: January 2012
History of Changes

October 10, 2008
January 16, 2012
July 2007
January 2009   (final data collection date for primary outcome measure)
  • Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. [ Time Frame: Day 0 through Day 60 post-vaccination ] [ Designated as safety issue: No ]
  • Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. [ Time Frame: Day 0 through Day 7 post-vaccination ] [ Designated as safety issue: No ]
    Solicited Injection Site Adverse Events: Erythema, Induration, Pain, Pruritus, Swelling, Rash. Solicited Systemic Adverse Events: Lymph Node Pain, Pyrexia (Temperature), Chills, Constipation, Diarrhoea, Fatigue, Headache, Malaise, Myalgia, Nausea, Vomiting, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Creatinine Increased, Haemoglobin Decreased, Platelet Count Decreased, White Blood Cell Count Increased.
  • Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. [ Time Frame: Day 0 through Day 60 post-vaccination 1 ] [ Designated as safety issue: No ]
  • Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine [ Time Frame: Day 15 through Month 10 Post-vaccination 1 ] [ Designated as safety issue: No ]
    Seroconversion was defined as an end point anti M2e antibody titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
  • Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine. [ Time Frame: Day 15 through Month 10 Post-vaccination 1 ] [ Designated as safety issue: No ]

    Antibody responses to the respective vaccines were assessed by means of enzyme linked immunosorbent assay (ELISA).

    A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ)
Safety and reactogenicity of ACAM-FLU-A with and without adjuvant compared to placebo control in healthy adult subjects. [ Time Frame: one and one half years ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00819013 on ClinicalTrials.gov Archive Site
  • Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. [ Time Frame: Month 4 through Month 10 post-vaccination 1 ] [ Designated as safety issue: No ]
    Participants who reported signs and symptoms of influenza were tested using nasal pharyngeal swabs, with secretions cultured using susceptible tissue culture cell lines. Positive cultures were confirmed as influenza using immunofluorescence techniques with influenza strain specific antibodies.
  • Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. [ Time Frame: Day 0 and Day 60 Post-vaccination 1 ] [ Designated as safety issue: No ]
    Seroconversion was defined as an antibody Titer ≥ 100. Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
  • Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. [ Time Frame: Day 0 and Day 60 Post-vaccination 1 ] [ Designated as safety issue: No ]

    Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA).

    A GMT value of 50.0 indicates a titer at or below the lowest limit of quantitation (LLOQ).

  • Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. [ Time Frame: Day 0 and Day 60 Post-vaccination 1 ] [ Designated as safety issue: No ]
    Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA).
  • Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. [ Time Frame: Day 0 and Day 15 through Month 10 post-vaccination 1 ] [ Designated as safety issue: No ]
    Antibody responses were assessed by means of enzyme linked immunosorbent assay (ELISA)
  • Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine. [ Time Frame: Day 0 and Day 15 through Month 10 Post-vaccination 1 ] [ Designated as safety issue: No ]

    Seropositivity with ELISA was defined as a Pre- or post-vaccination antibody titer ≥ 100. Seropositivity with the Commercial Kit method was defined as a positive pre- or post-vaccination response.

    Seropositivity were assessed by means of enzyme linked immunosorbent assay (ELISA) and the Commercial Kit methods
Immunogenicity profile following two doses of ACAM-FLU-A with and without adjuvant compared to placebo control. [ Time Frame: one and one half years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Safety, Reactogenicity, and Immunogenicity of Recombinant M2e Influenza-A Vaccine Candidate ACAM FLU-A) in Healthy Adults

This multi-center study will be conducted in the United States with up to 80 healthy adult subjects. Subjects will be scheduled to receive a total of two (2) injections with 1 injection each administered.

Subjects will be randomized according to a randomization scheme.
All subjects will be followed up for 60 days post-randomization and through the influenza season. Following the influenza season, a subset of the subjects will receive a booster vaccine at the 12 month time point. The subjects will further be assessed at 2 days, 7 days, 15 days, 30 days and 6 months following the booster vaccination.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Influenza
  • Biological: Influenza A Vaccine: ACAM FLU-A
    0.5 mL ACAM-FLU-A low dose + Adjuvant 1, Intramuscular
    Other Name: ACAM FLU-A
  • Biological: Influenza A Vaccine: ACAM FLU-A
    0.5 mL ACAM-FLU-A low dose + Adjuvant 2, Intramuscular
    Other Name: ACAM FLU-A
  • Biological: Influenza A Vaccine: ACAM FLU-A
    0.5 mL ACAM FLU-A low dose, Intramuscular
    Other Name: ACAM FLU-A
  • Biological: Saline placebo
    0.5 mL, Intramuscular
    Other Name: USP Saline
  • Experimental: Study Group 1
    ACAM-FLU-A low dose + Adjuvant 1
    Intervention: Biological: Influenza A Vaccine: ACAM FLU-A
  • Experimental: Study Group 2
    ACAM-FLU-A low dose + Adjuvant 2
    Intervention: Biological: Influenza A Vaccine: ACAM FLU-A
  • Experimental: Study Group 3
    ACAM-FLU-A low dose
    Intervention: Biological: Influenza A Vaccine: ACAM FLU-A
  • Placebo Comparator: Study Group 4
    Saline placebo
    Intervention: Biological: Saline placebo
Ibañez LI, Roose K, De Filette M, Schotsaert M, De Sloovere J, Roels S, Pollard C, Schepens B, Grooten J, Fiers W, Saelens X. M2e-displaying virus-like particles with associated RNA promote T helper 1 type adaptive immunity against influenza A. PLoS One. 2013;8(3):e59081. doi: 10.1371/journal.pone.0059081. Epub 2013 Mar 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
February 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult males or females 18 - 40 years of age in good general health

Exclusion Criteria:

  • Known allergies or severe reactions to any of the vaccine components including those to adjuvants
  • History of severe allergic reactions, including angioedema;
  • History of asthma or recurrent wheezing; (current or within past 2 years);
  • History of neurological symptoms or signs following administration of any vaccine;
Both
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00819013
H-261-001
No
Not Provided
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc
Sanofi
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP